510(k) K113272 ยท MRN Apparatus, Nitric Oxide Delivery
INOMAX DS(DELIVERY SYSTEMS
| Applicant | Ino Therapeutics, LLC/Dba Ikaria, Port Allen LA, US |
| Decision | Substantially Equivalent, Feb 29, 2012 |
| Received | Nov 4, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113272
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.